The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India
TROPION-Lung01, evaluating AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan versus chemotherapy, previously met the dual primary endpoint of progression-free survival in the overall trial population
The validations confirm the completion of the applications and commence the scientific review process
Clearance marks major shift beyond chemotherapy
Across more than 85 abstracts, AstraZeneca will showcase 10 approved medicines and 13 potential new therapies
The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)
Dr. Chand held several leadership positions within AstraZeneca and the broader biopharmaceutical industry
The new data highlight the potential of AstraZeneca’s innovative therapies to improve outcomes across multiple cancer types
Datroway becomes the first and only therapy to show overall survival benefit versus chemotherapy in this difficult-to-treat patient population
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
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